Non-tobacco oral nicotine pouch composition

ABSTRACT

A non-tobacco oral nicotine pouch composition is provided, including water in an amount of at least 15% by weight of the pouch composition; nicotine; and at least one sugar alcohol, the pouch composition being free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol. An oral pouched nicotine product is also provided, including a saliva-permeable pouch and the non-tobacco oral nicotine pouch composition enclosed in the saliva-permeable pouch.

FIELD OF INVENTION

The present invention relates to non-tobacco oral nicotine pouch compositions and oral pouched nicotine products according to the claims.

BACKGROUND

Delivery of nicotine by smoking has many well-known drawbacks, in particular health related problems, such as inclusion of carcinogenic substances.

However, tobacco substitutes also suffer from disadvantages, such as inadequate relief of cravings for the user.

A further challenge in the prior art is that the desired release of nicotine should be attractive to the user of the pouch from a user perspective.

Yet at further challenge in relation to the prior art may be that pouches as delivery vehicle for nicotine may be somewhat costly and thereby impose restrictions on the way pouches are designed in order to keep manufacturing costs in check.

It is an object of one embodiment of the present invention to provide a nicotine containing pouch, e.g. as a tobacco substitute, which may solve the above problems.

SUMMARY

The invention relates to a non-tobacco oral nicotine pouch composition comprising water in an amount of at least 15% by weight of the pouch composition, nicotine, and

at least one sugar alcohol, wherein the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose and glycerol.

An advantage of the invention may be that a combination of a high nicotine release rate may be obtained together with a desirable mouthfeel, hereunder softness and moisture feeling.

A further advantage of the invention may be that a desirable flavor perception may be obtained, facilitated by a combination of an improved flavor release and a desirable mouthfeel, hereunder softness and moisture feeling.

Advantages of the present invention may be improved release of nicotine, improved release of flavor, and improved flavor sensation without compromising the moisture mouth feel.

An even further advantage of the invention is that the combination of sugar alcohol, and water provides not only an attractive mouthfeel but also a very attractive taste profile.

Traditionally, humectants may be added to protect products from drying out and may also have a preservative effect.

A high water content can make the products vulnerable to microbial growth, such as growth of yeast, mold, and bacteria. This may not only compromise health safety but also leads to significant deterioration of the user experience, by visually alteration of the product, altering and deterioration of the taste etc. Surprisingly, the inventors found that the pouch composition according to the invention had a desirable taste and mouthfeel, such as softness and moisture feeling, even after significant time of storage.

A further advantage of the invention may be a surprisingly effective retention of water. Normally, retention of water is provided by including a humectant such as alginate, propylene glycol, hydroxypropyl cellulose, or glycerol. However, even though the pouch composition of the invention is free of these substances as humectants, an advantageously effective retention of water may be obtained.

In an embodiment of the invention, the pouch composition is free of humectants in the form of sugar alcohols comprising no more than three carbons. Examples of sugar alcohols comprising no more than three carbons include glycerol, propylene glycol, and ethylene glycol.

In an advantageous embodiment of the invention, the pouch composition is further free of humectants consisting of modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

Thus, in the above embodiment, the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, glycerol, modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

In an advantageous embodiment of the invention, the pouch composition comprises 0-0.4% by weight of humectants.

Thus, in the above embodiment, the pouch composition is free of humectants or comprises humectants in an amount of up to 0.4% by weight of the pouch composition.

In an advantageous embodiment of the invention, the pouch composition is free of humectants.

Thus, in the above embodiment, the pouch composition is free of any humectants, both alginate, sugar alcohols comprising no more than three carbons, hydroxypropyl cellulose, modified starch, triacetin, polyethylene glycol (PEG), pectin, xanthan gum and other humectants.

In an embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition, such as at least 15% by weight of the composition.

In an embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.

In an advantageous embodiment of the invention, the pouch composition comprises the at least one sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition, such as at least 15% by weight of the composition.

In an advantageous embodiment of the invention, the pouch composition comprises the at least one sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.

In an embodiment of the invention, the at least one sugar alcohol comprises sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, hydrogenated starch hydrolysates, and any mixture thereof.

As an example embodiment, hydrogenated starch hydrolysates may be used, which comprises a mixture of primarily maltitol, sorbitol and further sugar alcohols.

In an advantageous embodiment of the invention, the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol.

Traditionally, direct compressible ingredients are used to increase flowability of a powdered composition. Typically, when handing powdered compositions, flowability is used as a measure of the processability. However, when adding significant amounts of water to a sugar alcohol containing composition, the composition tends to agglomerate and the flowability is drastically reduced, possibly even to the point where it cannot be measured by conventional methods. Surprisingly, the present inventors found that the pouch composition of the invention comprising non-DC sugar alcohol was still processable in filling machinery into individual pouches. Thus, the present invention facilitates effective processing and thereby a cost-effective setup by enabling the use of non-DC sugar alcohol and by avoiding e.g. filling of the pouches by hand or very complex, special designed filling machinery.

It is noted that different sugar alcohols may be applied for the purpose of taste and salivation, where the sugar alcohol composition is made of different sugar alcohols having different properties with respect to storage, processability and/or taste.

In an advantageous embodiment of the invention, the at least one non-directly compressible (non-DC) grade sugar alcohol is selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.

In an advantageous embodiment of the invention, the pouch composition comprises non-directly compressible (non-DC) grade sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition, such as at least 15% by weight of the composition.

In an advantageous embodiment of the invention, the pouch composition comprises non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.

In an embodiment of the pouch composition comprises non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.

In an embodiment of the pouch composition comprises non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 10 to 70% by weight of the composition, such as 10 to 60% by weight of the composition, such as 15 to 60% by weight of the composition, such as 20 to 60% by weight of the composition, such as 20 to 50% by weight of the composition.

In an embodiment of the invention, xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof is used as the at least one non-directly compressible (non-DC) grade sugar alcohol.

In an embodiment of the invention, the at least one non-directly compressible (non-DC) grade sugar alcohol(s) are selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

In an embodiment of the invention, the pouch composition comprise at least one non-directly compressible (non-DC) grade sugar alcohol, such as at least two non-directly compressible (non-DC) grade sugar alcohols, such as at least three non-directly compressible (non-DC) grade sugar alcohols.

In an embodiment of the invention, the at least two non-directly compressible (non-DC) grade sugar alcohols are selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

In an embodiment of the invention, the at least three non-directly compressible (non-DC) grade sugar alcohols are selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

In an embodiment of the invention, the at least one sugar alcohol comprises directly compressible (DC) grade sugar alcohol.

In an embodiment of the invention, the directly compressible (DC) grade sugar alcohol comprises sugar alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any mixture thereof.

Sorbitol is in directly compressible (DC) grade from nature.

In an advantageous embodiment of the invention, the pouch composition comprises at least one further sugar alcohol.

In an embodiment of the invention, the pouch composition comprises the at least one further sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition, such as at least 15% by weight of the composition.

In an embodiment of the invention, the pouch composition comprises the at least one further sugar alcohol in an amount of 1 to 50% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 40% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 30% by weight of the composition.

In an advantageous embodiment of the invention, the at least one further sugar alcohol comprises directly compressible (DC) grade sugar alcohol.

In an embodiment of the invention, the at least one further sugar alcohol is directly compressible (DC) grade sugar alcohol.

In an embodiment of the invention, the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol(s) and the at least one further sugar alcohol comprises directly compressible (DC) grade sugar alcohol.

In an embodiment of the invention, the non-directly compressible (non-DC) grade sugar alcohol is selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof.

Sugar alcohols may advantageously facilitate and induce salivation of the pouch composition, whereby release of nicotine is obtained, such as of nicotine from the pouch.

Sugar alcohols may advantageously be used to further increase the nicotine release from the pouch.

Also, sugar alcohols may advantageously be used for obtaining a desirable mouthfeel by increasing salivation and thereby counteract any local dehydration or oral dehydrating sensation experienced by the user of the pouch.

In an embodiment of the pouch composition comprises non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.

In an embodiment of the pouch composition comprises non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 10 to 70% by weight of the composition, such as 10 to 60% by weight of the composition, such as 15 to 60% by weight of the composition, such as 20 to 60% by weight of the composition, such as 20 to 50% by weight of the composition.

In an embodiment of the invention, the at least one sugar alcohol comprises sugar alcohol selected from the list consisting of maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combination thereof.

In an embodiment of the invention the at least one sugar alcohol comprises sugar alcohol selected from the list consisting of maltitol, mannitol, isomalt, sorbitol, lactitol, and any combination thereof.

In an embodiment of the invention the at least one sugar alcohol comprises sugar alcohol selected from the list consisting of maltitol, mannitol, sorbitol, lactitol, and any combination thereof.

In an embodiment of the invention the pouch composition is free of DC-grade xylitol.

In an embodiment of the invention the pouch composition is free of xylitol.

In an embodiment of the invention the pouch composition is free of DC-grade sugar alcohol.

In an embodiment of the invention, the pouch composition comprises sugar alcohol in an amount of at least 14.0% by weight of the pouch composition.

In an embodiment of the invention, the pouch composition comprises at least one non-wheat fiber.

In an embodiment of the invention, the pouch composition comprises at least one non-sodium carbonate pH regulating agent.

In an embodiment of the invention, the pouch composition comprises pH regulating agent in an amount of more than 5.5% by weight of the pouch composition.

In an embodiment of the invention, the pouch composition comprises sodium chloride.

In an embodiment of the pouch composition comprises at least two non-direct compressible (non-DC) grade sugar alcohols selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.

In an advantageous embodiment of the invention, the non-directly compressible (non-DC) grade sugar alcohol(s) is provided as particles, which have not been subject to granulation or agglomeration steps.

The terminology directly compressible is well-known within the art of tableting, i.e. in technical field of compression of particles in a gathered compressed tablet. Directly compressible is routinely referred to as DC by many manufactures of such particles.

In an embodiment of the invention the at least one non-directly compressible (non-DC) grade sugar alcohol are defined as non-DC grade with reference to the Compressibility Index according to European Pharmacopeia 6.0 and where particles consisting of the non-DC grade sugar alcohol are having a compressibility index which is greater than 21%.

In an embodiment of the invention the at least one non-directly compressible (non-DC) grade sugar alcohol are defined as non-DC with reference to the Compressibility

Index according to European Pharmacopeia 6.0 and where particles consisting of the non-DC grade sugar alcohol are having a compressibility index which is greater than 21% and less than 37%.

In an embodiment of the invention the pouch composition comprises a further sugar alcohol, wherein said further sugar alcohol is directly compressible (DC).

In an embodiment of the invention said further sugar alcohol is defined as DC with reference to the Compressibility Index according to European Pharmacopeia 6.0 and where particles consisting of said further sugar alcohol are having a compressibility index which is less than 21%, such as less than 15%, such as less than 10%.

In an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount of at least 0.1% by weight, such as least 0.2% by weight of the pouch composition.

In an embodiment of the invention, the pouch composition comprises nicotine in an amount of 0.1 to 5.0% by weight of the pouch composition, such as 0.2 to 4.0% by weight of the pouch composition, such as 1.0 to 2.0% by weight of the pouch composition.

In an advantageous embodiment of the invention, the pouch composition comprises nicotine selected from the group consisting of a nicotine salt, nicotine free base, nicotine-ion exchange resin combination, a nicotine inclusion complex or nicotine in any non-covalent binding; nicotine bound to zeolites; nicotine bound to cellulose, such as microcrystalline cellulose, or starch microspheres, and mixtures thereof.

In an advantageous embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition.

In an advantageous embodiment of the invention, the nicotine-ion exchange resin combination comprises nicotine complexed with ion exchange resin.

In an advantageous embodiment of the invention, the nicotine-ion exchange resin combination is nicotine complexed with ion exchange resin.

Thus, in the above embodiment the nicotine-ion exchange resin combination consists of nicotine complexed with ion exchange resin.

In an advantageous embodiment of the invention, the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin.

One advantage of the above embodiment may be providing sustained release of nicotine. At the same time, the release rate of nicotine is not too slow to give the user the craving relief desired.

In an advantageous embodiment of the invention, the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight.

In an embodiment of the invention the nicotine-ion exchange resin combination comprises nicotine complexed with ion exchange resin, wherein the nicotine constitutes an amount of between 5 and 50% by weight of nicotine-ion exchange resin combination.

In an embodiment of the invention the nicotine-ion exchange resin combination consists of nicotine complexed with ion exchange resin, wherein the nicotine constitutes an amount of between 10 and 50% by weight of nicotine-ion exchange resin combination, such as between 10 and 40% by weight of nicotine-ion exchange resin combination, such as. between 10 and 30% by weight of nicotine-ion exchange resin combination, such as between 10 and 25% by weight of nicotine-ion exchange resin combination.

In an embodiment of the invention the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin, wherein the nicotine constitutes an amount of between 5 and 50% by weight of nicotine-ion exchange resin combination.

In an embodiment of the invention the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin, wherein the nicotine constitutes an amount of between 5 and 50% by weight of nicotine-ion exchange resin combination, such as .between 10 and 50% by weight of nicotine-ion exchange resin combination, such as .between 20 and 50% by weight of nicotine-ion exchange resin combination, such as between 25 and 50% by weight of nicotine-ion exchange resin combination, such as between 25 and 45% by weight of nicotine-ion exchange resin combination.

In an embodiment of the invention the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin, wherein the nicotine constitutes an amount of between 5 and 40% by weight of nicotine-ion exchange resin combination, such as between 10 and 40% by weight of nicotine-ion exchange resin combination, such as between 10 and 35% by weight of nicotine-ion exchange resin combination, such as between 10 and 25% by weight of nicotine-ion exchange resin combination, such as between 10 and 15% by weight of nicotine-ion exchange resin combination.

In an advantageous embodiment of the invention, the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 10 and 95% by weight.

In an embodiment of the invention the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 10 and 95% by weight.

In an embodiment of the invention the nicotine-ion exchange resin combination comprises nicotine in an amount of between 10 and 30% by weight and ion-exchange resin in an amount between 20 and 90% by weight.

In an embodiment of the invention the nicotine-ion exchange resin combination consist of nicotine in an amount of between 10 and 30% by weight and ion-exchange resin in an amount between 70 and 90% by weight.

In an embodiment of the invention the nicotine-ion exchange resin combination is substantially free of water.

In an embodiment of the invention the nicotine-ion exchange resin combination further comprises glycerol complexed with the ion-exchange resin.

Glycerol may be added with the purpose of reducing dustiness of the nicotine-ion exchange resin combination.

In an embodiment of the invention, the nicotine-ion exchange resin combination further comprises glycerol in an amount of 0.1 to 50% by weight, such as 5 to 40% by weight, such as 5 to 30% by weight.

In an embodiment of the invention the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 20 and 75% by weight.

In an embodiment of the invention the nicotine-ion exchange resin combination comprises water in an amount of no more than 75% by weight, such as no more than 50% by weight, such as no more than 40% by weight, such as no more than 30% by weight, such as no more than 20% by weight, such as no more than 10% by weight, such as no more than 5% by weight.

In an advantageous embodiment of the invention, the ion exchange resin comprises one or more resin(s) selected from the group consisting of:

(i) a methacrylic, weakly acidic type of resin containing carboxylic functional groups, (ii) a copolymer of methacrylic acid and divinylbenzene, said copolymer containing carboxylic functional groups, (iii) a polystyrene, strongly acidic type of resin containing sulphonic functional groups, (iv) a polystyrene, intermediate acidic type of resin containing phosphonic functional groups, and (v) a combination thereof.

In an advantageous embodiment of the invention, the ion exchange resin comprises polacrilex resin.

In an advantageous embodiment of the invention, the ion exchange resin is polacrilex resin.

In an embodiment of the invention, the polacrilex resin comprises or is Amberlite®IRP64.

In an advantageous embodiment of the invention, the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition.

In an embodiment of the invention, the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 20-65% by weight of the composition, such as 25-65% by weight of the composition.

In an embodiment of the invention, the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 15-40% by weight of the composition.

In an embodiment of the invention, the pouch composition comprises water in an amount of 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 15-40% by weight of the composition, such as 15-30% by weight of the composition.

In an embodiment of the invention, the pouch composition comprises water in an amount of 15-40% by weight of the composition.

The water may be added as a separate component to be fully or partly mixed into other components, such as fibers. E.g. when adding a nicotine ion-exchange resin combination consisting of a mixture of free base nicotine with ion exchange resin and water, a significant amount of water of the final pouch composition may come from this mixture. For example, if the final amount pouch composition comprises 5% water from the nicotine-ion exchange resin combination, then up to one third of the water in the pouch composition derives from the nicotine-ion exchange resin combination.

In an advantageous embodiment of the invention, the pouch composition comprises at least one water-insoluble fiber.

In an advantageous embodiment of the invention, the pouch composition comprises at least one water-insoluble fiber in an amount between 5 and 50% by weight of the pouch composition, such as 10-45% by weight of the pouch composition, such as 15-40% by weight of the pouch composition.

In an embodiment of the invention, the pouch composition comprises at least one water-insoluble fiber in an amount between 5 and 50% by weight of the pouch composition, such as 5-45% by weight of the pouch composition, such as 5-40% by weight of the pouch composition.

In an embodiment of the invention, the pouch composition comprises at least one water-insoluble fiber in an amount between 5 and 50% by weight of the pouch composition, such as 10-50% by weight of the pouch composition, such as 15-50% by weight of the pouch composition.

An advantage of the above embodiment may be that a residue is left even after use of a nicotine pouch comprising the pouch composition. This may lead to a pleasant perception for users of the nicotine pouch, e.g. due to similarity with tobacco containing products.

The water-insoluble fiber may advantageously provide a desirable mouthfeel throughout the use of the pouch.

A further advantage of the invention is that a very attractive soft, moist, and moldable texture and mouthfeel is obtained due to a combination of sugar alcohol, water-insoluble fiber and water. The desirable texture and mouthfeel may be obtained while still being able to store manufactured pouches together in abutment e.g. in cans etc. without sticking too much together to result in ruptures of the pouches when being removed.

In an advantageous embodiment of the invention, the water-insoluble fiber is a non-tobacco fiber.

In an advantageous embodiment of the invention, the water-insoluble fiber is a plant fiber.

In an advantageous embodiment of the invention, the water-insoluble fiber is selected from wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, cellulose fibers, bran fibers, bamboo fibers, powdered cellulose, and combinations thereof.

Powdered cellulose within the scope of the invention is understood to be cellulose prepared by processing alpha-cellulose obtained as a pulp from strains of fibrous plant materials, such as wood pulp.

In an embodiment of the invention, the water-insoluble fiber comprises or consists of cereal fibers.

In an embodiment of the invention, the water-insoluble fiber comprises or consists of fruit and/or vegetable fibers.

In an embodiment of the invention, the water-insoluble composition comprises or consists of water-insoluble fiber selected from wheat fibers, oat fibers, pea fibers, powdered cellulose, or combinations thereof.

In an embodiment of the invention, the water-insoluble composition comprises or consists of water-insoluble fiber selected from wheat fibers, oat fibers, pea fibers, or combinations thereof.

In an embodiment of the invention, the water-insoluble composition comprises or consists of water-insoluble fiber selected from wheat fibers, oat fibers, or combinations thereof.

Non-limiting examples of usable water-insoluble fibers include Vitacel WF 600, Vitacel HF 600, Vitacel P95, Vitacel WF 200, Vitacel LOO, Vitacel Erbsenfaser EF 150, Vitacel bamboo fiberbaf 90, Vitacel HF 600, Vitacel Cellulose L700G, Vitacel PF200, Vitacel potatofiber KF200, Vitacel bamboo fiberhaf BAF40, Vitacel Haferfaser/oat fiber HF-401-30 US.

Non-limiting examples of usable powdered cellulose include Vitacel L 00, Vitacel Cellulose L700G, Vitacel LC1000, Vitacel L600-20, Vitacel L600 etc.

In an embodiment, the powdered cellulose is chemically unmodified. Thus, powdered cellulose may be chemically unmodified cellulose fibers, which do not include e.g. microcrystalline cellulose (MCC).

In an advantageous embodiment of the invention, the water-insoluble fiber has a water binding capacity of at least 200%, such as at least 300%, such as at least 400%.

An advantage of the above embodiment may be that the high water-binding capacity enables pouch compositions having a high water-content.

Furthermore, the pouches having a high water-content where found to have a desirable texture and mouthfeel while it is still possible to store the manufactured pouches together in abutment e.g. in cans etc. without sticking too much together to result in ruptures of the pouches when being removed.

Also, water-insoluble fibers having a high water-binding capacity may reduce any nicotine exchange induced by the divalent cations happening prior to the pouch being used.

Hence, pouches comprising water-insoluble fibers having a high water-binding capacity could advantageously decrease the relative standard deviation (RSD) on the nicotine content.

In an advantageous embodiment of the invention, the content of nicotine between a series of at least 10 oral pouches comprising said pouch composition holds a relative standard deviation (RSD) below 10%, preferably below 8%, more preferably at most 6%, even more preferably at most 4%, most preferably at most 2%.

In an embodiment of the invention, the content of the nicotine between a series of at least 10 oral pouches comprising said pouch composition holds a relative standard deviation (RSD) of 0.1-10%, preferably 0.1-8%, more preferably 0.1-6%, even more preferably 0.1-4%, and most preferably 0.1-2%.

In an embodiment of the invention, the water-insoluble fiber has a water binding capacity of 300 to 1500%, such as 400 to 1300%.

In an embodiment of the invention, the water-insoluble fiber has a water binding capacity of 200% to 1500%, such as 300 to 1300%, such as 200 to 800%, such as 300 to 800%, such as 400 to 600%.

In an embodiment of the invention, the water-insoluble fiber has a water binding capacity of 200 to 1500%, such as 300 to 1300%, such as 300 to 900%, such as 300 to 700%, such as 400 to 700%.

In an embodiment of the invention, the water-insoluble fiber has a water binding capacity of 200 to 1500%, such as 400 to 1500%, such as 500 to 1500%, such as 500 to 1200%, such as 500 to 1000%.

In an embodiment of the invention, the water-insoluble fiber has a swelling capacity of at least 5.0 mL/g, such as 5.0-20 mL/g.

An advantage of the above embodiment is that the amount of water-insoluble fiber can be reduced without compromising the mouthfeel during use. If an amount of water-insoluble fiber is substituted for a water-soluble component, the swelling of the water-insoluble fiber will during use counteract the dissolution of the water-soluble component, thereby the user will not experience any decrease in pouch content during use.

In an embodiment of the invention, the water-insoluble fibers are selected from pea fibers, powdered cellulose, and combinations thereof, and wherein the pouch composition comprises flavor in an amount of no more than 10% by weight of the pouch composition.

In an embodiment of the invention, the pouch composition comprises water-insoluble fibers selected from pea fibers and powdered cellulose, or a combination thereof, and flavor in an amount of 0.01-10% by weight of the pouch composition.

In an advantageous embodiment of the invention, the water-insoluble fiber has a density of 50 to 500 gram per Liter, such as 100 to 400 gram per Liter, such as 200 to 300 gram per Liter.

The use of water-insoluble fiber having a relatively low bulk density, will provide not only a good mouthfeel, but also an effective release from the pouch, due to the fact that a relatively low bulk density promotes effective salivation, thereby dissolution and release of water-soluble ingredients of the composition.

In an advantageous embodiment of the invention, the pouch composition comprises a pH regulating agent.

In an advantageous embodiment of the invention, the pouch composition comprises pH regulating agent in an amount between 0.01 and 15% by weight of the pouch composition, such as between 0.5 and 10% by weight of the pouch composition, such as between 1 and 10% by weight of the pouch composition, such as between 5 and 10% by weight of the pouch composition.

Obtaining a relatively fast release rate of nicotine and an effective uptake/absorption may be desirable as this ensures a fast effect for the user, i.e. craving relief.

Furthermore, the combination of having an effective release and an effective absorption advantageously enables a relative high exploitation of the nicotine dose within the pouch. Having a relative high exploitation of the nicotine dose within the pouch may further provide a reduction of necessary nicotine dose of the pouch, without compromising the resulting effect. A lower nicotine dose may in tern result in a reduction in production cost, as nicotine may be relatively expensive, but may also assist users who want to lower their intake of nicotine.

In an advantageous embodiment of the invention, the pH regulating agent is a basic pH regulating agent, such as a basic buffering agent.

In an advantageous embodiment of the invention, the pH regulating agent is a buffering agent, such as a basic buffering agent.

In an embodiment of the invention, the pouch composition is adapted to give a pH of at least 8.0, such as a pH of at least 9.0, when 2.0 gram of pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate-buffer (pH adjusted to 7.4).

An advantage of the above embodiment may be that a relatively effective uptake of nicotine is facilitated due to the high pH value obtained.

A further advantage of the above embodiment may be that the need for preservative may be decreased or even eliminated and that low amounts of such preservatives may be used if not absent.

Also, the high pH value obtained may advantageously provide for a tingling sensation in the mouth which may be perceived as a desirable mouthfeel, e.g. due to resemblance with tobacco-based pouch products.

In an embodiment of the invention, the pH regulating agent is selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono-δ-lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, Sodium orthophosphate, Potassium orthophosphate, Calcium orthophosphate, Sodium diphosphate, Potassium diphosphate, Calcium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, Carbonic acid, Sodium carbonate, Sodium bicarbonate, Potassium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.

In an advantageous embodiment of the invention, the pH regulating agent is selected from the group consisting Sodium carbonate, Sodium bicarbonate, Potassium carbonate, and Magnesium carbonate; Potassium bicarbonate; trometamol; phosphate buffer, or any combination thereof.

In the present context the term trometamol refer to (tris(hydroxymethyl)aminomethane), also sometimes referred to as tris buffer.

In an embodiment of the invention, the pouch composition further comprises inorganic multivalent cations, such as inorganic divalent cations.

In an embodiment of the invention, the pouch composition further comprises inorganic multivalent cations selected from the group consisting of multivalent ions of calcium, magnesium, zinc, aluminum, barium, iron, manganese, copper, lead, cobalt, nickel, such as Ca2+, Mg2+, Zn2+, Al3+, Ba2+, Fe2+, Fe3+, Fe4+, Mn2+, Mn4+, Cu4+, or any combinations thereof, or from the group consisting of Ca2+, Mg2+, and any combination thereof.

In an advantageous embodiment of the invention, the pouch composition is adapted to release at least 30% nicotine within 10 minutes when exposed to in vitro conditions described in example 6A.

In an advantageous embodiment of the invention, the pouch composition comprises sodium chloride in an amount of 0.0-3.0% by weight of the pouch compositions, such as 0.05-1.0% by weight of the pouch composition, such as 0.1-1.0% by weight of the pouch composition.

NaCl may advantageously be added in small amounts, i.e. 0.0-3.0% by weight as a flavor enhancer. Adding higher amounts of NaCl could induce an undesirable taste or mouthfeel.

In an advantageous embodiment of the invention, the pouch composition further comprises a preservative.

The preservative may help to preserve the pouch composition against undesirable microbiological growths.

In an advantageous embodiment of the invention, the pouch composition further comprises a preservative in an amount of 0.05 to 0.5% by weight of the pouch composition, such as 0.1 to 0.2% by weight of the pouch composition.

Non-limiting examples of usable preservatives within the scope of the invention includes sorbic acid (E200) and salts thereof (e.g. sodium sorbate (E201), potassium sorbate (E202), calcium sorbate (E203)), benzoic acid (E210) and salts thereof (e.g. sodium benzoate (E211), potassium benzoate (E212), calcium benzoate (E213)).

In an advantageous embodiment of the invention, the pouch composition comprises less than 0.1% by weight of preservatives, such as less than 0.05% by weight of preservatives.

Thus, the pouch composition may comprise preservatives in an amount of 0 to 0.1% by weight of preservatives, such as in an amount of 0 to 0.05% by weight of preservatives. This includes zero content of preservatives, i.e. that the pouch composition is free of preservatives. The low amount or even absence of preservative may be realized by obtaining a relatively alkaline environment, such as by the use of free-base nicotine or by the use of alkaline buffering agents.

In an advantageous embodiment of the invention, the pouch composition is free of preservatives.

In an advantageous embodiment of the invention, the pouch composition is a non-tobacco pouch composition.

In an advantageous embodiment of the invention, the pouch composition comprises less than 2.0% by weight of tobacco, such as less than 1.0% by weight of tobacco, such as less than 0.5% by weight of tobacco, such as 0.0% by weight of tobacco.

In an embodiment of the invention, the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, glycerol, modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum and the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition.

In an embodiment of the invention, the pouch composition is free of humectants and the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition.

In an embodiment of the invention, the pouch composition comprises the at least one sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition and the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol.

In an embodiment of the invention, the pouch composition comprises the at least one sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition, and the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.

In an embodiment of the invention, the pouch composition comprises the at least one sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition and the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.

In an embodiment of the invention, the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof and in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition, such as 15 to 50% by weight of the composition.

In an embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition and the nicotine-ion exchange resin combination comprises nicotine complexed with ion exchange resin.

In an embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition and the nicotine-ion exchange resin combination is nicotine complexed with ion exchange resin.

In an embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition and the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin.

In an embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition and the nicotine-ion exchange resin combination is free-base nicotine mixed with ion exchange resin.

In an embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition and wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight.

In an embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition and wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 10 and 95% by weight.

In an embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and wherein the ion-exchange resin comprises one or more resin(s) selected from the group consisting of:

(i) a methacrylic, weakly acidic type of resin containing carboxylic functional groups, (ii) a copolymer of methacrylic acid and divinylbenzene, said copolymer containing carboxylic functional groups, (iii) a polystyrene, strongly acidic type of resin containing sulphonic functional groups, (iv) a polystyrene, intermediate acidic type of resin containing phosphonic functional groups, and (v) a combination thereof.

In an embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 10 and 95% by weight and wherein the ion-exchange resin comprises one or more resin(s) selected from the group consisting of:

(i) a methacrylic, weakly acidic type of resin containing carboxylic functional groups, (ii) a copolymer of methacrylic acid and divinylbenzene, said copolymer containing carboxylic functional groups, (iii) a polystyrene, strongly acidic type of resin containing sulphonic functional groups, (iv) a polystyrene, intermediate acidic type of resin containing phosphonic functional groups, and (v) a combination thereof.

In an embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and wherein the ion exchange resin is polacrilex resin.

In an embodiment of the invention, the pouch composition comprises nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight and ion-exchange resin in an amount between 10 and 95% by weight and wherein the ion exchange resin is polacrilex resin.

In an embodiment of the invention, the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition and nicotine in an amount of 0.1 to 5.0% by weight of the pouch composition, such as 0.2 to 4.0% by weight of the pouch composition, such as 1.0 to 2.0% by weight of the pouch composition.

In an embodiment of the invention, the pouch composition comprises water in an amount of 15-65% by weight of the composition, such as 15-60% by weight of the composition, such as 15-50% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition, nicotine in an amount of 0.1 to 5.0% by weight of the pouch composition, such as 0.2 to 4.0% by weight of the pouch composition, such as 1.0 to 2.0% by weight of the pouch composition and at least one water-insoluble fiber in an amount between 5 and 50% by weight of the pouch composition, such as 10-45% by weight of the pouch composition, such as 15-40% by weight of the pouch composition.

In an embodiment of the invention, the pouch composition comprises at least one water-insoluble fiber in an amount between 5 and 50% by weight of the pouch composition, such as 10-45% by weight of the pouch composition, such as 15-40% by weight of the pouch composition, wherein the water-insoluble fiber is selected from wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, cellulose fibers, bran fibers, bamboo fibers, powdered cellulose, and combinations thereof.

In an embodiment of the invention, the pouch composition comprises pH regulating agent in an amount between 0.01 and 15% by weight of the pouch composition, such as between 0.5 and 10% by weight of the pouch composition, such as between 1 and 10% by weight of the pouch composition, such as between 5 and 10% by weight of the pouch composition, and the pH regulating agent is selected from the group consisting Sodium carbonate, Sodium bicarbonate, Potassium carbonate, and Magnesium carbonate; Potassium bicarbonate; trometamol; phosphate buffer, or any combination thereof.

In an embodiment of the invention, the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.

In an embodiment of the invention, the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof, the non-directly compressible (non-DC) grade sugar alcohol(s) being provided as particles, which have not been subject to granulation or agglomeration steps.

The invention further relates to an oral pouched nicotine product comprising a saliva-permeable pouch and the pouch composition of the invention or any of its embodiments enclosed in said pouch.

In an advantageous embodiment of the invention, the pouched nicotine product comprises nicotine in an amount of 0.5 to 20 mg, such as 1.0 to 20 mg, such as 5.0 to 15 mg.

In an advantageous embodiment of the invention, the pouched nicotine product comprises nicotine-ion exchange resin combination in an amount of 1 to 100 mg.

In an embodiment of the invention the pouched nicotine product comprises nicotine-ion exchange resin combination in an of 1 to 100 mg, such as 20 to 100 mg, such as, 40 to 100 mg, such as 60 to 100 mg, such as 60 to 85 mg.

In an embodiment of the invention the pouched nicotine product comprises nicotine-ion exchange resin combination in an of 1 to 100 mg, such as 5 to 60 mg, such as, 10 to 50 mg, such as 10 to 40 mg, such as 25 to 40 mg.

In an embodiment of the invention, the pouched nicotine product is free of tobacco.

DETAILED DESCRIPTION

As used herein the term “pouch composition” refers to the composition for use in an oral pouch, i.e. in pouches for oral use. Also, the terms “pouch composition” and “nicotine pouch composition” is used interchangeably.

As used herein the term “pouch” is intended to mean a container typically formed by a web of a fibrous material enclosing a cavity. The pouch is pouch designed for administration of an active ingredient in the oral cavity, and thus it is adapted for oral use, it is non-toxic and not water-soluble. The fibrous material may e.g. form a woven or non-woven web or fabric. The pouch may for example be sealed by bonding two corresponding pieces of web or fabric to each other along their edges to form a cavity for the nicotine and the non-water-soluble composition. In order to release the nicotine, the pouch is made water-permeable so as to allow saliva from the oral cavity to penetrate the pouch and enter the cavity, where the saliva can come into contact with the nicotine, whereby the nicotine are released from the oral pouch.

As used herein the term “humectant” is understood as a moistening agent used to keep pouches moist, i.e. a humectant is added to the pouch composition with the purpose of keeping the pouch moist. Hence, the term humectant does not refer to substances added for other purposes, hereunder also hygroscopic substances added for other purposes, such as sugar alcohols, water-insoluble fibers and glycerol associated with ion-exchange resin in nicotine-ion exchange resin combinations, such as nicotine polacrilex. Examples of humectants include alginate, propylene glycol, hydroxypropyl cellulose, and glycerol. It is noted that when glycerol is included as a humectant, the glycerol is added as free glycerol and therefore liquid at room temperature. Further examples of humectants include triacetin, modified starch, pectin, xanthan gum, etc. The term humectant does not refer to sugar alcohols comprising 4 or more carbons. Also, the term humectant does not refer to fibers, such as water-insoluble fiber, such as wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, cellulose fibers, bran fibers, bamboo fibers, powdered cellulose, and combinations thereof. Also, the term humectant does not include e.g. NaCl.

As used here, a non-tobacco pouch composition refers to a non-tobacco based composition. In an embodiment of the invention, the non-tobacco pouch composition comprises at most 2% tobacco fibers, or is free of tobacco fibers.

As used herein the term “nicotine” refers to nicotine used as a refined/isolated substance. Nicotine may be isolated from tobacco and added to pouch compositions. Particularly, nicotine does not refer to tobacco materials having a content of nicotine. Thus, when referring to nicotine amounts also to be understood as the nicotine dose, the amounts refers to the amount of pure nicotine. Nicotine also covers nicotine not obtained from tobacco, often referred to as synthetic nicotine.

As used herein, the term “nicotine-ion exchange resin combination” refer to a combination comprising nicotine complexed with ion exchange resin and/or nicotine mixed with ion exchange resin.

As used herein, the term “nicotine complexed with ion-exchange resin” refers to nicotine bound to an ion exchange resin.

In the present context the term “free-base nicotine mixed with ion exchange resin” refers to a mixture comprising free-base nicotine and ion exchange resin. It is noted that even if some embodiments comprise a combination of nicotine complexed with ion exchange resin and nicotine in its free-base form mixed with ion exchange resin, the term “free-base nicotine mixed with ion exchange resin” requires the presence of nicotine in its free-base form. In some embodiments, the mixture is an aqueous mixture. Free-base nicotine and water is mixed with ion-exchange resin, whereby a mixture comprising both free-base nicotine and ion exchange resin is obtained. Free-base nicotine mixed with ion exchange resin is referred to as “premix” in the examples.

As used herein the term “powder composition” refers to composition in the form of powder, i.e. as a particulate material having a relatively small particle size, for example between 1 and 1200 micrometer. Particularly, by powder composition is not meant a powdered tobacco.

As used herein the term “free-base nicotine” refers to non-protonated form of nicotine, and therefore does not include nicotine salts or nicotine provided as a complex between nicotine and an ion exchange resin. Nevertheless, the free-base nicotine may be mixed with an amount of ion exchange resin or water-soluble compositions such as sugar alcohols or water-soluble fibers. While free-base nicotine includes both free-base nicotine extracted from tobacco as well as synthetically manufactured free-base nicotine, the free-base nicotine is not provided in the form of tobacco or powdered tobacco. Typically, free-base nicotine is provided as a liquid.

As used herein the term “water-insoluble” refers to relatively low water-solubility, for example a water-solubility of less than 0.1 gram of water-soluble composition or substance per 100 mL of water measured at 25 degrees Celsius, atmospheric pressure and pH of 7.0. When referring to “insoluble”, water-insoluble is meant unless otherwise stated.

As used herein the term “effective release” refers to the total release of nicotine over the release period of the experiment or the use period.

As used herein, the term “dissolve” is the process where a solid substance enters a solvent (such as oral saliva or water within the pouch) to yield a solution.

The pouches of the invention provide a nicotine release into the oral cavity. A release profile of nicotine may be obtained which both comprises a fast release period and a sustained release period.

As used herein the term “fast release” or “fast release period” may refer to the initial 2 minutes of the nicotine release profile, whereas the term “sustained release period refers” to the subsequent period of the release profile until end of experiment or end of use.

As used herein the term “fast release rate” refers to the released nicotine per minute within the initial 2 minutes.

In an embodiment of the invention the pouch composition comprises high intensity sweetener.

Preferred high intensity sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, such as acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside and the like, alone or in combination.

In an embodiment of the invention, the pouch composition comprises bulk sweeteners including sugar and/or sugarless components.

In an embodiment of the invention, the pouch composition comprises bulk sweetener in the amount of 1.0 to about 80% by weight of the pouch composition, more typically constitute 5 to about 70% by weight of the pouch composition, and more commonly 10 to 60% by weight of the pouch composition or 10-50% by weight of the pouch composition. In some embodiments, inclusion of certain ingredients may limit the about amounts of bulk sweetener further.

The sweeteners may often support the flavor profile of the pouch composition.

Sugar sweeteners generally include, but are not limited to saccharide-containing components commonly known in the art of pouches, such as sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated glucose syrup, and the like, alone or in combination.

The sugar sweetener can be used in combination with sugarless sweeteners. Generally, sugarless sweeteners include components with sweetening characteristics but which are devoid of the commonly known sugars and comprise, but are not limited to, sugar alcohols comprising 4 or more carbons, such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolyzates, maltitol, isomalt, erythritol, lactitol and the like, alone or in combination.

As used herein the term “flavor” is understood as having its ordinary meaning within the art. Flavor includes liquid and powdered flavors. Thus, flavors do of course not include sweeteners (such as sugar, sugar alcohols and high intensity sweeteners), or acids providing pure acidity/sourness, nor compounds providing pure saltiness (e.g. NaCl) or pure bitterness. Flavor enhancers include substances that only provide saltiness, bitterness or sourness. Flavor enhancers thus include e.g. sodium chloride, Citric acid, ammonium chloride etc.

The flavors can be natural or synthetic flavors.

In an embodiment of the invention the pouch composition comprises flavor. Flavor may typically be present in amounts between 0.01 and 15% by weight of the total composition of the pouch, such as between 0.01 and 5% by weight of the total composition.

Non-exhaustive examples of flavors suitable in embodiments of the present invention are coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits, cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essence such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essence. The essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above.

As used herein, the term “pH regulating agent” refers to agents, which active adjust and regulates the pH value of the solution to which they have been added or are to be added. Thus, pH regulating agents may be acids and bases, including acidic buffering agents and alkaline buffering agents. On the other hand, pH regulating agents does not including substances and compositions that can only affect the pH by dilution. Furthermore, pH regulating agents does not include e.g. flavoring, fillers, etc.

According to an embodiment of the invention, the enhancer comprises one or more pH-regulating agent, such as a buffering agent.

In an embodiment of the invention, said pH-regulating agents are selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono-δ-lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, Sodium orthophosphate, Potassium orthophosphate, Calcium orthophosphate, Sodium diphosphate, Potassium diphosphate, Calcium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, Carbonic acid, Sodium carbonate, Sodium bicarbonate, Potassium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.

Typically, the pouches comprise openings, where the characteristic opening dimension is adapted to a characteristic dimension of the matrix composition so as to retain the matrix composition inside the pouch before use and/or to retain a part of the matrix composition, such as an water-insoluble composition, inside the pouch during use.

In order to obtain a pouch having suitable opening dimensions in view of the matrix composition to be used, the material for the pouch may be selected accordingly, e.g. comprising e.g. woven and/or non-woven fabric.

In other words, according to the various embodiments, the pouch forms a membrane allowing passage of saliva and prevents or inhibits passage of said matrix composition. The membrane of the pouch may be of any suitable material e.g. woven or non-woven fabric (e.g. cotton, fleece etc.), heat sealable non-woven cellulose or other polymeric materials such as a synthetic, semi-synthetic or natural polymeric material. An example of suitable pouch material is paper made of pulp and a small amount of wet strength agent. A material suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from leaving the bag or pouch during use. Suitable materials are also those that do not have a significant impact on the release of nicotine from the pouch.

The pouch composition is filled into pouches and is maintained in the pouch by a sealing. An ideal pouch is chemically and physically stable, it is pharmaceutically acceptable, it is insoluble in water, it is easy to fill with powder and seal, and it provides a semi-permeable membrane layer which prevent the powder from leaving the bag, but permit saliva and therein dissolved or sufficiently small suspended components from the pouch composition in the pouch, such as nicotine, to pass through said pouch.

The pouch may be placed in the oral cavity by the user. Saliva then enters into the pouch, and the nicotine and other components, which are soluble in saliva, start to dissolve and are transported with the saliva out of the pouch into the oral cavity, where the nicotine may be absorbed.

EXAMPLES Example 1A—Preparation of Pouches Designed for Administration of Nicotine

The material of the pouches is heat sealable non-woven cellulose, such as long fiber paper. Pouches that are not in form of non-woven cellulose fabric may also be used according to the invention.

The powder is filled into pouches and is maintained in the pouch by a sealing.

Example 1B—Preparation of Pouches Designed for Administration of Nicotine

The material of the pouches is manufactured using rayon fibers, such as viscose rayon staple fibers. The pouch membrane is heat sealed along its edges except for an opening in one end into an inner cavity formed by the pouch membrane.

The powder is filled into pouches and is maintained in the pouch by a sealing.

Example 2: Preparation of Nicotine Premixes

A 60 liter planetary Bear Varimixer mixer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Then ion exchange resin Amberlite® IRP64 was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped down, if necessary. Finally the mixer was stirred for further 5 minutes at high speed. The total process time was 20 minutes.

Thereby, mixtures of nicotine and cation exchange resin were produced from the constituents stated in the below tables.

Premix I:

TABLE 1 Ingredients used to manufacture nicotine premix I (5.7% nicotine). % water in obtained nicotine-resin composition: 71.4 Constituent Amount (kg) Amount (%) Nicotine 1.0 5.7 Water 12.5 71.4 Resin 4.0 22.9 Total 17.5 100.0

Premix II:

TABLE 2 Ingredients used to manufacture nicotine premix II (13.2% nicotine). % water in obtained nicotine-resin composition: 34.1. Constituent Amount (kg) Amount (%) Nicotine 1.08 13.2 Water 2.80 34.1 Resin 4.32 52.7 Total 8.20 100.0

Premix III:

TABLE 3 Ingredients used to manufacture nicotine premix III (18.5% nicotine). % water in obtained nicotine-resin composition: 7.5. Constituent Amount (kg) Amount (%) Nicotine 1.08 18.5 Water 0.44 7.5 Resin 4.32 74.0 Total 5.84 100.0

Premix IV:

TABLE 4 Ingredients used to manufacture nicotine premix IV (10% nicotine). % water in obtained nicotine-resin composition: 50.0. Constituent Amount (kg) Amount (%) Nicotine 1.08 10.0 Water 5.40 50.0 Resin 4.32 40.0 Total 10.8 100.0

Premix V:

TABLE 5 Ingredients used to manufacture nicotine premix V (20% nicotine). % water in obtained nicotine-resin composition: 31.5. Constituent Amount (kg) Amount (%) Nicotine 1.78 20.0 Water 2.80 31.5 Resin 4.32 48.5 Total 8.90 100.0

Premix VI:

TABLE 6 Ingredients used to manufacture nicotine premix VI (30% nicotine). % water in obtained nicotine-resin composition: 27.5. Constituent Amount (kg) Amount (%) Nicotine 3.05 30.0 Water 2.80 27.5 Resin 4.32 42.5 Total 10.17 100.0

Premix VII

TABLE 7 Ingredients used to manufacture nicotine premix VII (35% nicotine). % water in obtained nicotine-resin composition: 25.6. Constituent Amount (kg) Amount (%) Nicotine 3.83 35.0 Water 2.80 25.6 Resin 4.32 39.4 Total 10.95 100.0

Premix VIII:

TABLE 8 Ingredients used to manufacture nicotine premix VIII (42% nicotine). % water in obtained nicotine-resin composition: 22.8. Constituent Amount (kg) Amount (%) Nicotine 5.15 42.0 Water 2.80 22.8 Resin 4.32 35.2 Total 12.27 100.0

Example 3: Preparation of Pouch Compositions

Pouches are prepared comprising powdered compositions as outlined in table 9-21. The pouches are made as follows.

Fibers and water are mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients were added subsequently under continuous mixing: first the nicotine (mixed for 2 minutes), then the remaining ingredients except liquid flavor and glidant if any (mixed for 2 minutes), then liquid flavor if any (mixed for 1 minute), then glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.

Example 4: Preparation of Filled Pouches

The final pouch composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A or 1B may be used. The powder is filled into pouches and is maintained in the pouch by a sealing.

Example 5A: Pouches

The pouch compositions are prepared from the ingredients in table 9 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 9 Pouch compositions. Pouches P01 P02 P03 P04 C1 C2 C3 C4 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 25 20 15 10 27 27 27 content [wt %] Raw material Content in weight percent NPR (16%) 12.1 12.1 12.1 12.1 12.1 12.1 12.1 12.1 Non-DC 18.9 20.9 30.9 40.9 45.9 16.9 16.9 16.9 xylitol Purified 27 25 20 15 10 27 27 27 water Wheat fiber 25 25 20 15 15 25 25 25 Sodium — — — — — 2.0 — — alginate Glycerol — — — — — — 2.0 — Hydroxy- — — — — — — — 2.0 propyl cellulose Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5B: Pouches

The pouch compositions are prepared from the ingredients in table 10 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 10 Pouches P10 P11 P12 P13 C5 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 27 25 20 15 10 Raw material Content in weight percent Premix VI 6.4 6.4 6.4 6.4 6.4 Non-DC xylitol 26.6 28.6 38.6 48.6 53.6 Purified water 25 23 18 13 8 Wheat fiber 25 25 20 15 15 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 Flavor 8.9 8.9 8.9 8.9 8.9 High intensity 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5C: Pouches

The pouch compositions are prepared from the ingredients in table 11 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 11 Pouch compositions. Pouches P20 P21 P22 P23 C6 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 27 25 20 15 10 Raw material Content in weight percent Premix II 14.6 14.6 14.6 14.6 14.6 Non-DC xylitol 21.4 23.4 33.4 43.4 48.4 Purified water 22 20 15 10 5 Wheat fiber 25 25 20 15 15 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 Flavor 8.9 8.9 8.9 8.9 8.9 High intensity 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5D: Pouches

The pouch compositions are prepared from the ingredients in table 12 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 12 Pouch compositions. Pouches P30 P31 P32 P33 P34 P35 P36 P37 P38 Amount of 9.6 mg 9.6 mg 9.6 mg 4.8 mg 7.2 mg 12.0 mg 4.8 mg 7.2 mg 12.0 mg nicotine Water 27 27 27 27 27 27 27 27 27 content [wt %] Raw material Content in weight percent NPR (16%) 12.1 — — 6.1 9.0 15.1 — — — Premix II — 14.6 — — — — — — — Premix VI — — 6.4 — — — 3.2 4.8 8.0 Non-DC 18.9 21.4 26.6 24.9 22.0 15.9 28.6 27.5 25.2 xylitol Purified 27 22 25 27 27 27 26.2 25.7 24.8 water Wheat fiber 25 25 25 25 25 25 25 25 25 Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100

Pouch content: 500 mg total.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5E: Pouches

The pouch compositions are prepared from the ingredients in table 13 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 13 Pouch compositions. Pouches P40 P41 P42 P43 P44 P45 P46 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 4.8 mg 7.2 mg 12.0 mg nicotine Water 27 27 27 27 27 27 27 content [wt %] Raw material Content in weight percent NPR (16%) — 7.0 — — — — — NBT 5.9 2.3 2.3 2.3 — — — Premix II — — 8.5 — 7.3 10.9 18.2 Premix VI — — — 3.7 — — — Non-DC 25.1 21.7 23.1 26.0 26.2 23.8 19.0 xylitol Purified 27 27 24.1 26.0 24.5 23.3 20.8 water Wheat fiber 25 25 25 25 25 25 25 Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100

Pouch content: 500 mg total.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5F: Pouches

The pouch compositions are prepared from the ingredients in table 14 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 14 Pouch compositions. Pouches P50 P51 P52 P53 P54 P55 P56 P57 P58 C14 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 30 30 30 30 30 30 30 30 30 35 content [wt %] Raw material Content in weight percent Premix VI 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 Non-DC 5.0 — 5.0 — — 7.0 5.0 5.0 — xylitol Xylitol DC — — — — — — 5.0 — — — Non-DC — 21.6 — — — — — — — — Isomalt Isomalt DC — — — — — — — 16.6 — — Sorbitol — — 16.6 — — — — — — — Mannitol DC — — — — — — — — 16.6 — Non-DC — — — 21.6 — — — — — — Mannitol Non-DC — — — — 21.6 — — — — — Maltitol Non-DC 16.6 — — — — 14.6 16.6 — — — Erythritol Purified 28 28 28 28 28 28 28 28 28 33 water Wheat fiber 27 27 27 27 27 27 27 27 27 43.6 Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5G: Pouches

The pouch compositions are prepared from the ingredients in table 15 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 15 Pouch compositions. Pouches P60 P61 P62 P63 P64 P65 P66 P67 P68 C15 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 27 27 27 27 27 27 27 27 35 content [wt %] Raw material Content in weight percent Premix II 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 Non-DC 5.0 — 5.0 — — 7.0 5.0 5.0 — xylitol Xylitol DC — — — — — — 5.0 — — — Non-DC — 19.4 — — — — — — — — Isomalt Isomalt DC — — — — — — — 14.4 — — Sorbitol — — 14.4 — — — — — — — Mannitol DC — — — — — — — — 14.4 — Non-DC — — — 19.4 — — — — — — Mannitol Non-DC — — — — 19.4 — — — — — Maltitol Non-DC 14.4 — — — — 12.4 14.4 — — — Erythritol Purified 22 22 22 22 22 22 22 22 22 33 water Wheat fiber 27 27 27 27 27 27 27 27 27 35.4 Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 511: Pouches

The pouch compositions are prepared from the ingredients in table 16 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 16 Pouch compositions. Pouches P70 P71 P72 P73 P74 P75 P76 P77 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 27 27 20 20 30 20 30 content [wt %] Raw material Content in weight percent Premix VI 6.4 6.4 6.4 6.4 6.4 6.4 6.4 6.4 Non-DC 26.5 26.5 26.5 50.5 30.5 — 30.5 — Xylitol Xylitol DC — — — — — 5.0 — 5.0 Non-DC — — — — — 28.5 — 20.5 Erythritol Purified 25 25 25 18 18 28 18 28 water Wheat fiber — — — 10 30 15 — 15 Oat fiber 27 — — — — — 30 — Pea Fiber — 27 — — — — — — Powdered — — 27 — — — — — Cellulose Sodium 5.0 5.0 5.0 5.0 5.0 3.5 5.0 5.0 carbonate Sodium — — — — — 3.5 — — hydrogen- carbonate Flavor 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 NaCl — — — — — — — 10 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium carbonate and optionally sodium hydrogen carbonate are used as alkaline buffering agents. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5I: Pouches

The pouch compositions are prepared from the ingredients in table 17 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 17 Pouch compositions. Pouches P80 P81 P82 P83 P84 P85 P86 P87 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 27 27 20 20 35 20 35 content [wt %] Raw material Content in weight percent Premix II 14.6 14.6 14.6 14.6 14.6 14.6 14.6 14.6 Non-DC 21.3 21.3 21.3 45.3 25.3 20.3 25.3 20.3 Xylitol Purified 22 22 22 15 15 30 15 30 water Wheat fiber — — — 10 30 20 — — Oat fiber 27 — — — — — 30 20 Pea Fiber — 27 — — — — — — Powdered — — 27 — — — — — Cellulose Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus” or “Vitacel 200WF”.

Oat fiber, trade name “Vitacel HF 600”.

Pea fiber, trade name “Vitacel EF150”.

Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, powdered cellulose, cellulose fibers, apple fibers, cocoa fibers, bamboo fibers, bran fibers, and cellulose fiber.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5J: Pouches

The pouch compositions are prepared from the ingredients in table 18 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 18 Pouch compositions. Pouches P90 P91 P92 P93 P94 P95 P96 P97 P98 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 27 27 27 27 27 27 27 27 content [wt %] Raw material Content in weight percent NPR (16%) 12.1 12.1 12.1 12.1 12.1 12.1 12.1 12.1 12.1 Non-DC 5.0 — 5.0 — — — 5.0 5.0 5.0 Xylitol Xylitol DC — — — — — 5.0 — — — Non-DC — 18.8 — — — — — — — Isomalt Isomalt DC — — — — — — — — — Sorbitol — — 13.8 — — — — — — Non-DC — — — 18.8 — — — — — Mannitol Mannitol DC — — — — — — — — — Non-DC — — — — 18.8 — — — — Maltitol Non-DC 13.8 — — — — 13.8 13.8 13.8 13.8 Erythritol Purified 27 27 27 27 27 27 27 27 27 water Wheat fiber 27 27 27 27 27 27 — — — Oat fiber — — — — — — 27 — — Pea Fiber — — — — — — — 27 — Powdered — — — — — — — — 27 Cellulose Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus” or “Vitacel 200WF”.

Oat fiber, trade name “Vitacel HF 600”.

Powdered cellulose, trade name “Vitacel LOO” or “Vitacel L700G”.

Pea fiber, trade name “Vitacel EF150”.

Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, powdered cellulose, cellulose fibers, apple fibers, cocoa fibers, bamboo fibers, bran fibers, and cellulose fiber.

Sodium carbonate, sodium hydrogen carbonate and/or trometamol are used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5K: Pouches

The pouch compositions are prepared from the ingredients in table 19 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 19 Pouch compositions. Pouches P 100 P 101 P 102 P 103 P 104 P 105 P 106 P 107 C16 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 27 27 27 27 27 27 27 27 35 content [wt %] Raw material Content in weight percent NPR (16%) 12.1 12.1 12.1 12.1 12.1 — — — 12.1 Premix VI — — — — — 6.4 6.4 6.4 — Non-DC 16.9 19.4 11.9 14.9 14.9 27.6 20.6 20.6 — Xylitol Purified 27 27 27 27 27 27 27 27 35 water Wheat fiber 27 27 27 27 27 27 27 27 37.8 Sodium 5.0 2.5 10.0 3.5 — — 3.5 — 5.0 carbonate Sodium — — — 3.5 — — 3.5 — — hydrogen- carbonate Trometamol — — — — 7.0 — — 7.0 — Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 7.0 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium carbonate, sodium hydrogen carbonate and/or trometamol are used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5L: Pouches

The pouch compositions are prepared from the ingredients in table 20 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 20 Pouch compositions. Pouches P110 P111 P112 P113 P114 P115 P116 P117 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 30 30 30 30 30 30 30 27 content [wt %] Raw material Content in weight percent NPR (16%) — — — — 12.1 12.1 12.1 — Premix II 14.6 14.6 — — — — — 14.6 Premix VI — — 6.4 6.4 — — — — CaCl₂ 1.3 2.0 1.3 2.0 1.0 1.3 2.0 — Non-DC 12.1 11.4 17.3 16.6 9.9 9.6 9.9 7.0 Xylitol Non-DC — — — — — — — 16.3 Erythritol Purified 25 25 28 28 30 30 30 22 water Wheat fiber 30 30 30 30 30 30 30 27 Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 5.0 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 5M: Pouches

The pouch compositions are prepared from the ingredients in table 21 using preparation method described in example 3.

The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).

TABLE 21 Pouch compositions. Pouches P120 P121 P122 P123 C17 C18 C19 C20 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 30 30 30 30 30 30 30 30 content [wt %] Raw material Content in weight percent Premix II 14.6 — 14.6 — 14.6 — 14.6 — Premix VI — 6.4 — 6.4 — 6.4 — 6.4 CaCl₂ 1.0 1.0 — — 1.0 1.0 — — Non-DC 12.4 17.6 13.4 18.6 10.4 15.6 9.4 14.6 Xylitol Purified 25 28 25 28 25 28 25 28 water Wheat fiber 30 30 30 30 30 30 30 30 Sodium — — — — 2.0 2.0 2.0 2.0 alginate Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 NaCl — — — — — — 2.0 2.0 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100

Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants. Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.

Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

Flavor example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.

Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

Example 6A: Pouch Release Experiments (In Vitro)

The release properties of the pouches were tested in an in vitro experiment.

Reaction tubes having a diameter approx. 2 cm and containing 10 mL of 0.02 M potassium dihydrogen phosphate-buffer (pH adjusted to 7.4) were warmed to 37 degrees Celsius. One reaction tuber per timepoint was used.

A pouch was submerged in the buffer of the first reaction tube using tweezers. After a specified time period, the pouch was captured with the tweezer and gently swirled in the buffer before being removed from the first reaction tube and added to the next reaction tube, representing the next time point. The procedure was repeated until the desired number of time points had been tested.

The whole release experiment was performed at 37 degrees Celsius. No stirring or shaken was applied during the release experiment.

The amount of release nicotine was determined by analyzing the buffer samples at the different timepoints using standard HPLC.

Example 6B: Release Experiment on Pouch P 120-123

The release experiment was performed as described in example 6A.

TABLE 22 Shows the percentage of nicotine released from nicotine pouches at different timepoints with and without CaCl₂ and with or without alginate. Pouch C19 C17 C20 C18 P122 P120 P123 P121 Nicotine premix II II VI VI II II VI VI Humectant Alginate Alginate Alginate Alginate None None None None CaCl₂ (wt %) — 1.0 — 1.0 — 1.0 — 1.0 Min. Released nicotine (%) 2 13.8 12.9 20.8 24.0 16.2 29.5 26.9 38.7 5 25.7 26.0 39.8 42.9 28.6 50.9 47.4 58.2 10 37.5 40.3 59.0 61.7 42.0 64.8 66.0 74.8 30 60.4 62.3 79.4 82.6 59.2 78.7 79.5 92.2

Evaluation: the results demonstrate increased release of nicotine from pouches not comprising sodium alginate.

Also, the result shows that the presence of CaCl₂ increases the release of nicotine from pouches. The presence of CaCl₂ increases both the initial release rate and seems to also increase the effective release of nicotine.

Furthermore, the results demonstrate that increasing the nicotine content of the premixes also increases the nicotine release from the pouches.

Example 7A: Weight-Loss Over Time

Pouch compositions with different humectants (comparative formulations) and without humectants were prepared and directly placed in open containers at 25 degrees Celsius and 60% RH (relative humidity).

TABLE 23 shows relative weight-loss in % from comparative pouch compositions with varying humectants and from pouch compositions without humectants. Time Pouch Humectant 1 week 2 weeks 3 weeks 4 weeks P1 — 0.68 1.14 1.37 2.51 C2 Alginate 0.96 1.53 2.11 3.64 C3 Glycerol 1.05 1.68 2.10 3.77 C4 Hydroxypropyl 1.15 2.08 2.54 4.39 cellulose

Evaluation: the results demonstrate a higher weight-loss from pouch compositions comprising humectants selected from alginate, glycerol, and hydroxypropyl cellulose.

Example 8A: User Evaluation

The produced pouches of the invention were evaluated and found highly suitable as delivery vehicles of nicotine in that they provide a favorable release of nicotine and at the same time are pleasant to the user, e.g. with respect to a desirable mouthfeel such as a moist and moldable texture and a desirable taste.

Example 8B: User Evaluation

Pouches were evaluated by a test-panel of 4 trained assessors. Each assessor evaluated all samples twice. The test-panel evaluated the pouches on 2 different parameters over 15 min: overall taste and sweetness intensity.

The test was performed on pouches with two different flavors.

Pouch P117-1 corresponds to P117 with lemon and orange flavor.

Comparative P117-C1, which is based on P117, but with 2.0% alginate, 10.0% flavor (lemon and orange) and where the content of erythritol is adjusted to obtain a total of 100%.

Pouch P117-2 corresponds to P117 with raspberry and liquorice.

Comparative P117-C2, which is based on P117, but with 2.0% alginate, 10.0% flavor (raspberry and liquorice) and where the content of erythritol is adjusted to obtain a total of 100%.

TABLE 24 Overall taste Sweetness intensity Minutes P117-C1 P117-1 P117-C2 P117-2 P117-C1 P117-1 P117-C2 P117-2 0.5 3.5 4 3 4 3.5 4 3 4 1 3.5 4 3 4 3.5 4 3 4 3 3.5 4.5 3.5 4.5 4 4.5 3 4.5 5 4 4 3.5 4 4 4 3 4 10 4 4 3.5 4 4 4 3 4 15 4 4 3.5 3.5 4 4 3 3.5

Evaluation: the test panel found that pouches P117-1 and P117-2 without alginate and a lower amount of flavor scored similarly or even higher on overall taste and sweetness intensity during the test period when compared to pouches P117-C1 and P117-C2 with alginate and a higher amount flavor.

Surprisingly, the inventive pouches P117-1 and P117-2 were found to score higher on both overall taste and sweetness during the initial time of use, i.e. use up to 5 min. Also, the inventive pouches P117-1 and P117-2 were found to score similarly or higher in the period from 5 to 15 min of use, despite the lower amount of flavor in the inventive pouches P117-1 and P117-2 tested. 

1.-43. (canceled)
 44. A non-tobacco oral nicotine pouch composition, comprising: water in an amount of at least 15% by weight of the pouch composition; nicotine; and at least one sugar alcohol, wherein the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol.
 45. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition is further free of humectants consisting of modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.
 46. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition comprises 0-0.4% by weight of humectants.
 47. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition is free of humectants.
 48. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition comprises the at least one sugar alcohol in an amount of at least 1% by weight of the composition.
 49. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol.
 50. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof.
 51. The non-tobacco oral nicotine pouch composition according to claim 49, wherein the non-directly compressible (non-DC) grade sugar alcohol(s) is provided as particles, which have not been subject to granulation or agglomeration steps.
 52. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition comprises the nicotine in an amount of at least 0.1% by weight.
 53. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, nicotine-ion exchange resin combination, a nicotine inclusion complex or nicotine in any non-covalent binding, nicotine bound to zeolites, nicotine bound to cellulose, and mixtures thereof.
 54. The non-tobacco oral nicotine pouch composition according to claim 44, further comprising a nicotine-ion exchange resin combination in an amount corresponding to 0.1 to 20% by weight of the pouch composition.
 55. The non-tobacco oral nicotine pouch composition according to claim 54, wherein the nicotine-ion exchange resin combination comprises nicotine complexed with ion exchange resin.
 56. The non-tobacco oral nicotine pouch composition according to claim 54, wherein the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin.
 57. The non-tobacco oral nicotine pouch composition according to claim 54, wherein the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight.
 58. The non-tobacco oral nicotine pouch composition according to claim 54, wherein the ion-exchange resin comprises one or more resins selected from the group consisting of: (i) a methacrylic, weakly acidic type of resin containing carboxylic functional groups, (ii) a copolymer of methacrylic acid and divinylbenzene, the copolymer containing carboxylic functional groups, (iii) a polystyrene, strongly acidic type of resin containing sulphonic functional groups, (iv) a polystyrene, intermediate acidic type of resin containing phosphonic functional groups, and (v) a combination thereof.
 59. The non-tobacco oral nicotine pouch composition according to claim 54, wherein the ion-exchange resin comprises polacrilex resin.
 60. The non-tobacco oral nicotine pouch composition according to claim 44, wherein the pouch composition comprises the water in an amount of 15%-65% by weight of the composition.
 61. The non-tobacco oral nicotine pouch composition according to claim 44, further comprising at least one water-insoluble fiber.
 62. The non-tobacco oral nicotine pouch composition according to claim 61, wherein the at least one water-insoluble fiber is a non-tobacco fiber.
 63. The non-tobacco oral nicotine pouch composition according to claim 61, wherein the water-insoluble fiber is a plant fiber.
 64. The non-tobacco oral nicotine pouch composition according to claim 44, further comprising a pH regulating agent.
 65. An oral pouched nicotine product comprising a saliva-permeable pouch and the pouch composition of claim 44 enclosed in the saliva-permeable pouch. 